NCT06346808Not yet recruitingPhase 1
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 4 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Mar 2024
- Start date
- 1 May 2024
- Primary completion date
- 1 May 2026
- Lead sponsor
- Sichuan University
- Diseases
- Pancreatic cancer
- NCT number
- NCT06346808
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 1 May 2024 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
- Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
- Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
- Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
Other illness
- Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
- Serious uncontrolled medical conditions that may interfere with the subject's ability to receive treatment as specified in the protocol, including, but not limited to, positive HIV test, active tuberculosis, and DNA copy number of HBV \>103/ml;
- Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
- Those who may be allergic to the study drug or any of its excipients;
Other
- Pregnant or lactating women;
- Preoperative ultrasound evaluation of patients with small tumor size, location near or behind major blood vessels, and various other factors that may result in a low success rate of intra-tumoral viral injection under ultrasound and a high rate of post-injection complications;
- Any uncertainty that affects patient safety or compliance.
Who the study is looking for
- \- Age ≥18 years and age ≤75 years. ECOG score 0-1. Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer
- Adequate bone marrow and organ function:
- Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
- Signed informed consent. Ability to comply with the study protocol and follow-up.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.